1. Field of the Invention
The present invention relates to a transport container for transporting sterile products from a sterilization facility to a downstream facility for the intended use of the products, and the sterile docking with the downstream facility, comprising two connecting devices which are arranged opposite one another and one of which is equipped with a rapid transfer port for docking the transport container with the downstream facility and the other is a filling apparatus.
The products are, for example, small parts, such as caps or stoppers for pharmaceutical uses. The downstream facility is, for example, a filling plant for pharmaceutical products. Thus, during docking of the transport container, the purity and the sterility of the products and of the parts with which the products come into contact must be ensured.
2. Description of the Prior Art
For the cleaning and sterilization of caps and stoppers in the pharmaceutical industry, various processes for treatment and various methods for docking with the next production stage are known.
A customary process comprises cleaning and sterilizing the closure parts in a treatment facility and, after the treatment, filling them into a transport and storage container. The filled container is then undocked from the treatment facility. The container is usually subjected to pressure so that contamination of the closure parts from the atmosphere is ruled out.
If required, the containers are moved to the next process step, for example a filling machine. Usually, the further processing takes place in a clean room or in an isolator. A docking process takes place there. What is decisive is that, during the further processing, the closure parts never come into contact with an unclean environment, i.e. an environment which is not clean and not sterile. All docking processes must therefore be effected under sterile conditions so that no contamination of the closure parts with the atmosphere can take place. In this case, the container has only the function of a storage and transport container. No treatment of the content takes place therein.
After the treated closure parts have been introduced into the transport and storage container, a rapid transfer port known per se is manually fastened to the filling opening. The attached adapter must then be cleaned and sterilized with known agents. After this process, the storage container is ready for docking at the next process stage. This method has the disadvantage that firstly a manual operation is necessary with the attachment of the port and that secondly the cleaning and sterilization of the port cannot be carried out simultaneously with the process.
Another known process comprises treating the closure parts in a multifunctional container and then storing and transporting them in this container.
In order to achieve good cleaning and sterilization results, large amounts of cleaning agents, air for drying and steam for sterilization are required. These media must as a rule flow from bottom to top through the material. The multifunctional container therefore requires an upper and a lower process connection so that the required media can flow through the material. After the treatment, the multifunctional container is undocked from the treatment facility. The closure parts are transported and stored in the multifunctional container under superatmospheric pressure.
For the further use, the procedure is as in the case of the first process. In order to permit both the cleaning and sterilization treatment and the docking in the subsequent process stage, the multifunctional container is equipped at the top with a Y-connection. One connection serves for carrying out the process and the other is equipped with a rapid transfer port. With this facility, it is possible to mount the rapid transfer port firmly on the container. Manual attachment of the port is dispensed with. The port is equipped with a cover. A disadvantage of this method is that the media (cleaning agent, steam) cannot flow through the port, which is bacteriologically disadvantageous, since it is good practice for the medium to flow completely through the parts in contact with products during the cleaning and during the sterilization.
An additional disadvantage is the fact that the port seal is not cleaned and not sterilized, since the port cover is not removed during the cleaning and sterilization process. In addition, the construction of the Y-connection is very complicated. However, this construction is necessary in this process since the process connections cannot be used as port connections.
During the docking process, the material falls downward and mechanical means (in this case by means of a screen) have to be used to prevent the material from falling in the direction of the process connection.
U.S. Pat. No. 5,490,546 discloses a transport container having an outlet opening arranged on its bottom and a filling opening for sterile or hazardous products, arranged opposite on the top. Both openings are provided with caps, which are opened by means of actuating devices present there during docking with a pipe, another container or the like. This transport container, too, has the above-mentioned disadvantage with regard to the possibility of incomplete cleaning and sterilization.